Pharmaceutical Technology-03-02-2016

March 02, 2016

Integrated data and cloud-based solutions can be used for process optimization.

March 02, 2016

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

March 02, 2016

Policy makers debate strategies for promoting access to less costly medicines.

March 02, 2016

Siegfried Schmitt, principal consultant, PAREXEL, discusses how the regulatory requirements for CGMPs is the different phases of drug development and manufacture.

March 02, 2016

Data integrity is a widespread, global problem that must be addressed.

March 02, 2016

Slides from the FDA GDUFA presentation before the Senate Health, Education, Labor and Pensions Committee in January 2016.

March 02, 2016

Thought leaders tackle drug shortages and manufacturing innovations.

March 02, 2016

Gauging the adequate level and type of screening is the challenge when identifying relevant crystalline forms.

March 02, 2016

Standardized testing protocols are crucial for acceptance of single-use systems.

March 02, 2016

The Spark 20M multimode microplate reader has the ability to read 6- to 1536-well microplates and includes a high-frequency xenon flash lamp that can be combined with detection modules.

March 02, 2016

The Dionex Integrion High-Pressure Ion Chromatography system from Thermo Scientific includes high-pressure capability and electrochemical detection.

March 02, 2016

The Zeiss Smartproof 5 wide-field confocal microscope is designed for applications in quality assurance and quality control, production, and R&D laboratories.

March 02, 2016

The pharma outsourcing market starts 2016 with expansions, acquisitions, and new offerings.

March 02, 2016

Supply-chain success is measured by how effectively new medications reach patients, and how swiftly manufacturers can react to internal and external changes.

March 02, 2016

The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.

March 02, 2016

Choosing the right facility size requires tailoring the design for current needs as well as anticipating the future.

March 02, 2016

There are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).

March 02, 2016

As specialty API outsourcing grows, manufacturers and contract development and manufacturing organizations are investing for the long haul.

March 02, 2016

Data integrity has become a more serious compliance problem at pharmaceutical manufacturing plants throughout the world.

March 02, 2016

The IH-TMS Tool Management System from I Holland monitors tool rotations, tooling inventory, and maintenance.

March 02, 2016

High Speed Dispersers from Ross feature a National Electrical Manufacturers Association (NEMA) 7&9 Operator Panel and grounding systems.

March 02, 2016

March 02, 2016

The Class 100 cleanroom oven from Grieve is used for a variety of heat processes such as sterilizing, depyrogenation, curing, and drying workloads.

March 02, 2016

Click the title above to open the Pharmaceutical Technology March 2016 issue in an interactive PDF format.